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FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

11/25/2014 - Draft Guidance Drug Compounding FDA FDCA Final Guidance Outsourcing Facilities Pharmacies Registration Reporting Requirements Section 503

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

10/20/2014 - Biotechnology FCC FDA Medical Devices ONC

FDA Takes First Steps Towards Regulating Laboratory Developed Tests

On July 31, the Food and Drug Administration (FDA or “the Agency”) notified Congress that it intends to issue draft guidance proposing a Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (“Draft...more

8/14/2014 - CLIA Clinical Laboratories Diagnostic Tests FDA Medical Devices

FDA Accepts First Biosimilar Application under New Approval Pathway

July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more

7/29/2014 - Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars FDA Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

7/3/2014 - CGMP DQSA Drug Compounding Drug Manufacturers FDA Manufacturers Outsourcing Pharmaceutical Prescription Drugs

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